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FDA Wants More Viaskin Peanut Data Resulting in Further Approval Delays
Delays mount pushing trials of modified patch.
DBV Optimistic Viaskin Peanut “Patch” Therapy has Path to Approval After FDA Feedback
DBV, which also has Viaskin therapies for milk and egg allergies in their pipeline, is encouraged by FDA feedback after denial of their peanut therapy.
Viaskin Peanut “Patch” Therapy Takes Next Step Toward Approval… in Europe
The Marketing Authorization Application for Viaskin™ Peanut was validated by the European Medicines Agency.
FDA Denies Approval of Viaskin Peanut “Patch” Therapy
The FDA raised concerns that adhesion of the patch would affect the efficacy of the therapy.
Will the Viaskin “Patch” Therapy for Peanut Allergy be Approved Soon? The Company is...
Company is restructuring in anticipation of delays.
FDA Has Questions About Viaskin Peanut Efficacy, Delays Meeting with DBV Technologies
The company warned the FDA's target date for their decision on approval could be delayed.
FDA Advisory Committee Meeting to Review Viaskin Peanut for the Treatment of Peanut Allergy...
Next step in the approval process for the therapy scheduled for May 15, 2020.
DBV Technologies Reports Positive Three-Year, Long Term Data from Phase III Open-Label Extension Study...
Patients demonstrated durable, long-term clinical benefit with an additional two years of treatment.
DBV Technologies Announces FDA Acceptance of BLA filing for Viaskin Peanut for the Treatment...
If approved, Viaskin Peanut would be the first and only epicutaneous immunotherapy indicated for this potentially life-threatening condition in children.
DBV Technologies Submits Biologics License Application to FDA for Viaskin Peanut for the Treatment...
This submission addresses the additional data needed on manufacturing procedures and quality controls which were communicated by the FDA in December.
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